Anatomic Pathology (AP) is the study of solid tissue, and is often a critical part of many protocols. Tissue samples are used in clinical trials in addition to the usual blood and urine samples. Examples of anatomic pathology samples Covance Central Laboratory Services receives for clinical trials are tissue from the gastrointestinal and urinary tracts, endometrium, liver, skin, lung and bone marrow.

Accurate patient identification is of utmost importance when sending Anatomic Pathology specimens as in almost all cases, unlike blood or urine samples, solid tissue samples cannot be recollected. Therefore the audit trail must be tighter and specimen ID is held to the highest standard. Imperfect specimen ID may result in the specimen being returned to the investigator site.

Tissue samples can be submitted in various forms; Wet tissue, Tissue in a paraffin block, or Tissue on a slide.
Some tissue samples are newly obtained from patients during the course of a clinical trial. These fresh samples are normally submitted “wet” in formalin.

They are identified with the barcode accession number affixed to the Covance CLS provided sample container and the Patient ID written on the label and the requisition. Be sure to write the patient ID using indelible marker on the accession label that matches the requisition.

Some tissue samples may be submitted from an archive of tissue samples from a patient. These archival samples may be already labeled using local hospital or clinical procedures. When the Sponsor wants to use these tissues for analysis, it is extremely important to provide a durable and defensible audit trial….tying the local patient identifiers to the Covance accession number used in the clinical trial.

Some tissue samples may be submitted from an archive of tissue samples from a patient. These archival samples may be already labeled using local hospital or clinical procedures. When the Sponsor wants to use these tissues for analysis, it is extremely important to provide a durable and defensible audit trial….tying the local patient identifiers to the Covance accession number used in the clinical trial.

Archival AP samples are normally submitted along with a copy of the local pathologist’s report which includes the sample’s local identification. Use the extra accession label from within the Covance CLS kit and apply it to the local lab report. This ties the local lab report to the clinical trial. Handwrite the patient’s clinical trial patient number or initials on the label. Also, be sure to use a black marker to obscure any confidential information such as patient’s name, address, social security number, etc.

In a sampling of specimens received at Covance CLS, we found AP sample identification errors to be 10 times the error rate for blood and urine samples! In order to preserve unique tissue samples we want to share successful practices with you. These will reduce the error rate ensuring the sample can be used for inclusion and analysis in the clinical trial. Please review the eLearning on Anatomic Pathology Sample ID for tips in proper labeling to prevent common sample identification errors.

By working together, we can reduce specimen identification errors and increase delivery of accurate results. Careful attention to specimen identification promotes quality patient care and a successful clinical trial.

Covance Central Laboratory Services Logistics would like to provide the following information regarding potential courier service delays due to Hurricane Irma.

Investigator Sites in Florida can expect to experience unavoidable service delays by your courier, based on the current or anticipated severe weather in your area. Although contingency plans are in place, some disruption in pickup or delivery service is anticipated by all couriers in Florida.

If your site is located in the impacted area, sample collections should be avoided if at all possible. Contact your normal courier prior to sample collection to confirm if pickup is available in your area.

If you have already drawn samples and your courier is unable to provide sample pickup, please maintain your specimens at the designated transport temperature until the next available pickup. Maintain ambient samples at ambient temperature, frozen samples in a frozen state in a freezer or on dry ice, refrigerated samples should be kept refrigerated.

Couriers will resume normal service schedules as soon as the situation allows. You can obtain further courier service weather updates by visiting your courier’s websites (ups.com or fedex.com).

If you have any questions regarding this information please contact Covance Investigator Support at 866-762-6209.

If a data revision has been requested for change of collection date, time, weight, visit, etc., the request may take up to 8 to 10 business days.

Once the change is complete, a fax will be sent to the site reporting the change has been made. A new report will not be sent. If a new report is needed please call Covance at the number listed for your area in the Contacts’ section of the laboratory manual.

There is a new and improved website just for you! The new Investigator Services website is up and running and contains numerous resources for investigator sites.

We gathered all the resources that sites might want and listed them so you could easily find what you needed on one page. What’s available: Everything from training videos, to centrifuge instructions, to contact numbers and much more.

Go to Covance.com to see the new page and bookmark it or add it to your favorites so you will have easy access to these resources.

These certifications are only updated in the investigator manual once per year during an annual Standard Page Update period. The link currently listed in the investigator manual is no longer in operation.

A project number is another way to identify your Covance protocol. This information is particularly useful when ordering kits and supplies as it identifies which arm/phase/branch/region applies to your study. Project numbers are six-digits long and can be found on the cover of your Covance Laboratory Manual and on every requisition in the left, lower corner.

Covance Central Laboratory Services recommends centrifuging specimens at 1500-2000g for 15 minutes. Failure to follow this suggestion could result in hemolysis, fragmentation of platelets, formation of microclots/clots, variability in results and an increased number of cancelations.

Should you need to make changes to this recommendation, please contact the study Sponsor in case of possible negative impacts in study data.